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NCT01360866 · ClinicalTrials.gov registry record · Phase 3
Safety and Tolerability of Oral OPC-34712 as Adjunctive Therapy in Adults With Major Depressive Disorder (the Orion Trial)
A Phase 3 study, sponsored by Otsuka Pharmaceutical Development & Commercialization.
- Completed
- Registry status
- Phase 3
- Development phase
- 2,944
- Enrollment target
NCT01360866: Completed Phase 3 study, sponsored by Otsuka Pharmaceutical Development & Commercialization.
NCT01360866 is a Phase 3 study that has completed, run by Otsuka Pharmaceutical Development & Commercialization. The registered enrollment target is 2,944 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (281% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01360866, a Phase 3 study, has completed, sponsored by Otsuka Pharmaceutical Development & Commercialization.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 2,944 participants
- Enrollment target
Study Summary
To assess the long-term safety and tolerability of oral OPC-34712 (brexpiprazole), given in addition to an FDA approved antidepressant (ADT) for the treatment of adults with Major Depressive Disorder (MDD)
Primary Outcome
To assess the frequency and severity of AEs as the variables of safety and tolerability of brexpiprazole.
Interventions
- DRUG Escitalopram
- DRUG Sertraline
- DRUG Fluoxetine
- DRUG OPC-34712
- DRUG Paroxetine CR
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2,944 participants |
| Start Date | 2011-10 |
| Est. Completion | 2017-05-18 |
| Phase | Phase 3 |
What the finished NCT01360866 record still lists
NCT01360866 is an interventional study that assigns participants to a tested intervention. Its 2,944 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (281% higher).
The record links to 0 conditions, and to 5 interventions - of which Escitalopram is the first listed.
NCT01360866 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01360866 about?
NCT01360866 is a clinical study titled "Safety and Tolerability of Oral OPC-34712 as Adjunctive Therapy in Adults With Major Depressive Disorder (the Orion Trial)". To assess the long-term safety and tolerability of oral OPC-34712 (brexpiprazole), given in addition to an FDA approved antidepressant (ADT) for the treatment of adults with Major Depressive Disorder (MDD)
What is the current status of trial NCT01360866?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 2,944 participants. The study started on 2011-10. Estimated completion is 2017-05-18.
What interventions are being tested in trial NCT01360866?
The interventions under investigation include: Escitalopram (DRUG), Sertraline (DRUG), Fluoxetine (DRUG), OPC-34712 (DRUG), Paroxetine CR (DRUG).
Who is sponsoring clinical trial NCT01360866?
This trial is sponsored by Otsuka Pharmaceutical Development & Commercialization, which has 221 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01360866's enrollment target sits among peer trials
2,944 80th of 2000 higher than 1,921 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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